Feds Extend HIPAA Obligations, Violation Penalties

Key Takeaways for Hospitalist Groups

• Covered entities and business associates should review their business associate agreements and determine whether the agreements qualify for grandfathered status and, if needed, enter into new business-associate agreements.
• Covered entities and business associates will need to review their policies and procedures so that they can implement all necessary changes in a timely manner.
• Notices of Privacy Practices will need to be revised, and appropriate training should be provided to personnel of covered entities and business associates.
• Any vendor or business that performs functions for a covered entity or another business associate involving the use or disclosure of PHI should determine whether it is a “business associate” and, if so, what needs to be done in order to comply with the Final Rule.

On Jan. 17, 2013, the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) issued an omnibus Final Rule implementing various provisions of the Health Information Technology for Economic and Clinical Health, or HITECH, Act. The Final Rule revises the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the interim final Breach Notification Rule.

The HITECH Act, which took effect as part of the American Recovery and Reinvestment Act of 2009, expanded the obligations of covered entities and business associates to protect the confidentiality and security of protected health information (PHI).

Under HIPAA, “covered entities” may disclose PHI to “business associates,” and permit business associates to create and receive PHI on behalf of the covered entity, subject to the terms of a business-associate agreement between the parties. A “covered entity” is defined as a health plan, healthcare clearinghouse, or healthcare provider (e.g. physician practice or hospital) that transmits health information electronically. In general, the HIPAA regulations have traditionally defined a “business associate” as a person (other than a member of the covered entity’s workforce) or entity who, on behalf of a covered entity, performs a function or activity involving the use or disclosure of PHI, such as the performance of financial, legal, actuarial, accounting, consulting, data aggregation, management, administrative, or accreditation services to or for a covered entity.

Prior to the HITECH Act, business associates were contractually obligated to maintain the privacy and security of PHI but could not be sanctioned for failing to comply with HIPAA. The HITECH Act expands those obligations and exposure of business associates by:

1. Applying many of the privacy and security standards to business associates;
2. Subjecting business associates to the breach-notification requirements; and
3. Imposing civil and criminal penalties on business associates for HIPAA violations.

In addition, the HITECH Act strengthened the penalties and enforcement mechanisms under HIPAA and required periodic audits to ensure that covered entities and business associates are compliant.

Expansion of Breach-Notification Requirements

The Final Rule expands the breach-notification obligations of covered entities and business associates by revising the definition of “breach” and the risk-assessment process for determining whether notification is required. A use or disclosure of unsecured PHI that is not permitted under the Privacy Rule is presumed to be a breach (and therefore requires notification to the individual, OCR, and possibly the media) unless the incident satisfies an exception, or the covered entity or business associate demonstrates a low probability that PHI has been compromised.1 This risk analysis is based on at least the following four factors:

1. The nature and extent of the PHI, including the types of identifiers and the likelihood of re-identification;
2. The unauthorized person who used or accessed the PHI;
3. Whether the PHI was actually acquired or viewed; and
4. The extent to which the risk is mitigated (e.g. by obtaining reliable assurances by a recipient of PHI that the information will be destroyed or will not be used or disclosed).